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ViveBio, LLC Enters Worldwide Exclusive Licensing Agreement with Renovar Inc. for Novel Urine-based Biomarker Technologies Covering Kidney Disease and Transplant Monitoring

ViveBio, LLC recently announced that it has signed a worldwide exclusive licensing agreement with Renovar, Inc. for urine based biomarkers to predict and monitor kidney diseases as well as rejection in transplant recipients. Based upon unique inflammatory protein signatures found in the urine of diseased or injured kidney’s, the Renovar technology can be used to assess the health of a patients kidney’s, guide therapeutic decision making and help stratify patients by risk for developing acute rejection.

ClinMet Metabolomics Platform Offers Unique Insights into Diabetic Kidney Disease

ClinMet recently announced that researchers from The University of California, San Diego School of Medicine have published new metabolomics research that uncovers a novel, characteristic and highly consistent biochemical signature in urine associated with diabetic kidney disease. The findings, which form a foundation of ClinMet’s proprietary Clinical Metabolomics platform, have implications for the identification of clinically useful biomarkers for kidney function and for sharpening drug development and clinical trials related to chronic kidney disease, as well as to diabetes, obesity and cardiovascular disease.

Exosome Diagnostics Enters Collaboration Agreement with Lilly for Exosome Blood-Based Biomarker Discovery

Exosome Diagnostics recently announced it has entered into a collaboration agreement with Eli Lilly and Company (NYSE: LLY) for biomarker discovery and validation using Exosome Diagnostics proprietary EXO50 nucleic acid extraction kit. Under the agreement, Lilly will gain early access to Exosome Diagnostics technology to help identify key gene mutations and expression levels in blood that may be correlated with drug response and disease recurrence. Financial terms were not disclosed.

“Exosome Diagnostics technology may provide a unique opportunity to gain insight into the biology of complex conditions such as cancer and immune disorders,” said Andrew Schade, senior medical director, diagnostic and experimental pathology at Lilly. “Exosome technology enables biofluid molecular sampling and the ability to monitor disease progression in real time. As Lilly explores new ways to pursue patient tailoring, we’ll continue to work with partners to expand our capabilities.”

“Accessing high quality messenger and microRNA directly from frozen patient fluid samples offers a rapid, cost-effective route to identify and validate biomarkers, which may be correlated with drug response and disease recurrence,” said James McCullough, chief executive officer of Exosome Diagnostics. “Lilly has accumulated an extensive and well annotated clinical blood sample biobank that provides a unique opportunity to track target biomarkers through the clinical trial process and help overcome the limitations of stored biopsy tissue.”

Exosomes and other microvesicles are secreted by all cells into all biofluids, and provide a natural biological packaging and distribution mechanism for RNA and DNA. Exosome Diagnostics’ rapid exosome isolation and extraction technology produces high-quality RNA and DNA, including full length mRNA and microRNA, from small volumes of patient biofluids, such as blood (serum and plasma), urine and cerebrospinal fluid, for analysis by standard PCR, array and sequencing instruments. Analysis can be performed on fresh or frozen fluid samples, allowing for broad, flexible and convenient analyses of clinical trial samples, both in real-time and retrospectively, with no special preservation methods required. Exosomes and their protected nucleic acid contents are being investigated in a broad range of diseases including cancer, CNS disorders such as Alzheimer’s and Parkinson’s disease, cardiovascular disease, maternal/fetal medicine, and chronic kidney disease, among others. In July, QIAGEN and Exosome Diagnostics signed an agreement for the creation of High-Performance Biofluid Sample Preparation Kits for Personalized Healthcare Research which covers the exclusive supply of these products upon availability in 2014.

Source: Exosome Diagnostics

Mount Sinai Launches First-ever Genetic Testing Program in the Primary Care Setting

The Icahn School of Medicine at Mount Sinai is partnering with the Institute for Family Health to launch the first-ever genetic testing program in the primary care setting to identify genetic risk for kidney disease in patients with hypertension.

The program will be funded through a $3.7 million grant from the National Human Genome Research Institute of the National Institutes of Health. Primary-care providers will use patients’ genomic information at the point-of-care to individualize treatment, testing and monitoring with Mount Sinai’s Clinical Implementation of Personalized Medicine through Electronic Health Records and Genomic Program, or CLIPMERGE, a novel clinical-decision support engine for delivering guidelines with genetic variants of clinical significance to enhance treatment.

Recent research has shown that one in eight African Americans have two copies of a version of the APOL1 gene, putting them at four to five times greater risk for developing chronic kidney disease or end-stage kidney disease if they have hypertension, or high blood pressure.

“Many patients do not have their blood pressure adequately controlled,” said Erwin Bottinger, MD, Director of the Charles Bronfman Institute for Personalized Medicine at the Icahn School of Medicine at Mount Sinai, and one of two principal investigators of the grant. “We believe that with genomic information made available to doctors through a patient’s electronic health record, we will be able to achieve better and stricter control of blood pressure and targeted use of medications that inhibit the renin angiotensin system, which are recommended in hypertensive patients at risk for kidney disease. More comprehensive tracking will also help ensure that optimal tests will be performed to stop progression of kidney disease.”

A cluster-randomized controlled trial will be conducted at 12 primary care sites in New York, including practices at The Mount Sinai Medical Center and the Institute for Family Health, which operates an independent network of community health centers in Manhattan and the Bronx.

“Genes are another piece of the puzzle that may help explain why people of African descent have poorer health outcomes than people of European descent,” said Carol Horowitz, MD, MPH, co-principal investigator and co-director of the Icahn School of Medicine at Mount Sinai’s new Center for Health Equity and Community Engaged Research. “We look forward to engaging with and helping educate our multicultural community partners, providers, and patients about the emerging role genetic testing will play in improving health.”

Neil Calman, MD, President and Chief Executive Officer of the Institute for Family Health, and Professor and Chair of Family Medicine and Community Health at Mount Sinai said, “Community-based primary care physicians have had little opportunity to incorporate genomics into the care of patients, and this grant offers us a tremendous opportunity. We hope to screen patients, identify those with increased genetic risk and work with them to prevent kidney disease. We will also train community-based primary care providers in how to discuss genetic risk with patients and their families and how to use genetic-based information in the electronic health record.”

Source: EurekAlert!

DaVita Labs and Myriad RBM Announce Biomarker Research Collaboration

DaVita Labs, a unit of DaVita HealthCare Partners Inc. (NYSE:DVA) and Myriad RBM, a wholly-owned subsidiary of Myriad Genetics (Nasdaq:MYGN) announced today a research collaboration to conduct protein biomarker discovery research with the goal of developing and commercializing diagnostic tests that could benefit in the treatment of dialysis patients.

DaVita and Myriad have identified potential opportunities where novel diagnostic tests utilizing blood-based protein biomarkers could improve the quality of life for patients and potentially lower overall healthcare costs. The primary area of focus will include the prediction of vascular access failure.

“This collaboration uses DaVita’s proprietary biorepository that is intended to facilitate innovative research across renal disease,” said Chris Rucker, president of DaVita Labs and DaVita Clinical Research. “Myriad recognizes the value that the biorepository can bring to research and development activities, and we look forward to collaborating with Myriad on the research and development of novel diagnostics that could transform our industry.”

“We are enthusiastic to collaborate with a company of the caliber of DaVita in the field of dialysis, one of the largest health care service markets,” said Craig Benson, president Myriad RBM. “We have extensive experience with research in kidney disease and inflammatory markers that we believe could increase the quality of care for dialysis patients.”

Specimens from the DaVita biorepository will be processed on the Myriad RBM DiscoveryMAP® platform for the quantification of more than 300 important proteins. DiscoveryMAP analyzes protein biomarkers correlated with inflammatory, metabolic and renal disease conditions that could have meaningful utility as diagnostic criteria for dialysis patients. Myriad is expected to begin processing specimens associated with this collaboration in fiscal year 2014.

Source: Myriad Genetics